Ziprasidone for the Treatment of Generalized Anxiety in Patients With Bipolar Disorder

This study has been terminated.
(Recruitment goal could not be achieved)
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Naomi M. Simon, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00374543
First received: September 8, 2006
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

This study proposes to examine the potential safety and efficacy of ziprasidone for patients with anxiety and bipolar disorder on anxiety outcomes, bipolar symptoms, and on measures of quality of life and resilience.


Condition Intervention Phase
Generalized Anxiety Disorder
Bipolar Disorder
Drug: Ziprasidone
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ziprasidone for the Treatment of Generalized Anxiety Comorbidity in Patients With Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    The 14-item Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959) was developed to assess anxiety in a clinical population. It is considered a measure of general anxiety across anxiety disorders, in addition to being a gold standard measure for GAD.

    Due to study termination, there are not results for primary and secondary outcome measures.



Secondary Outcome Measures:
  • Clinical Global Impression of Improvement (CGI-I) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    A secondary categorical outcome of response will be defined as a Clinical Global Impression Improvement Score (CGI-I) of 1 or 2. The CGI-I is a 7 point clinician-rated scale that assesses symptom improvement or worsening relative to a previous assessment. Lower ratings reflect greater improvement.

    Due to study termination, there are not results for primary and secondary outcome measures.



Enrollment: 3
Study Start Date: February 2006
Study Completion Date: November 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ziprasidone
Ziprasidone will be dosed on a twice daily (BID) basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day, for 8 weeks. This time period reflects the rapid onset of effect seen in studies of atypical antipsychotics, but allows time for a potentially longer response for some anxiety symptoms.
Drug: Ziprasidone
Ziprasidone, flexibly dosed from 40 to 160 mg/day, for 8 weeks.
Other Name: Geodon
Placebo Comparator: Placebo Capsules
Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
Drug: Placebo
Placebo administered daily for 8 weeks
Other Name: Control

Detailed Description:

This study would be the first prospective, placebo-controlled study to our knowledge of any pharmacotherapy strategy for the treatment of comorbid generalized anxiety (or any comorbid anxiety) in patients with bipolar disorder. Our hypotheses are:

  1. Ziprasidone flexibly dosed from 40 to 160 mg/day will reduce anxiety symptoms significantly more than placebo in patients with bipolar disorder who have a full or subsyndromal diagnosis of generalized anxiety disorder (GAD).
  2. Ziprasidone will be well tolerated in patients with generalized anxiety based on the incidence of treatment emergent adverse effects during 8 weeks of therapy, and based on a lack of worsening of bipolar depression, mania or hypomania compared to placebo.
  3. Treatment with ziprasidone will have a significantly greater positive impact on measures of quality of life and resilience than placebo.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female outpatients, aged 18 to 75 years.
  • Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II).
  • Current diagnosis of Generalized Anxiety Disorder (GAD).
  • Participants must be on at least one of the following mood stabilizers at steady dose for at least 4 weeks prior to randomization: lithium with blood levels between 0.4-1.4 meq/L, valproic acid/divalproate sodium (with levels between 50-150 ugm/dl) carbamazepine (blood levels between 4-12 mcg/ml), or lamotrigine (dosed 50-400 mg/day).

Exclusion Criteria:

  • Pregnant or lactating women or others not using acceptable means of birth control (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, implanted progesterone rods stabilized for at least 3 months).
  • Patients with current or history of schizophrenia, or patients with current mania, hypomania at study entry. Lifetime psychosis and dementia are exclusionary.
  • Patients with current obsessive-compulsive disorder or posttraumatic stress disorder are excluded.
  • Patients with a history of alcohol or substance abuse or dependence within the last three months.
  • Patients with significant unstable medical illness likely to result in hospitalization or acute medical care. In addition, patients with an established diagnosis of diabetes mellitus are excluded.
  • Current cognitive behavioral therapy directed toward the treatment of generalized anxiety disorder.
  • History of hypersensitivity to or lack of response to ziprasidone.
  • Concomitant treatment with other typical or atypical antipsychotics; patients should be off other typical or atypical antipsychotics for at least one week prior to study baseline.
  • Patients with significant suicidal ideation or who have enacted suicidal behaviors within 3 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
  • Patients who have had a psychiatric hospitalization (including for bipolar disorder) in the past 3 months are excluded.
  • Seizure disorders with the exception of a history of febrile seizures if they occurred during childhood, were isolated, and did not recur in adulthood.
  • History of Neuroleptic Malignant Syndrome.
  • Individuals with current clinically significant orthostatic hypotension are excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374543

Locations
United States, Massachusetts
Center for Anxiety and Traumatic Stress Disorders at Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Pfizer
Investigators
Principal Investigator: Naomi M. Simon, M.D. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Naomi M. Simon, Director, Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00374543     History of Changes
Other Study ID Numbers: 2006-P-000142
Study First Received: September 8, 2006
Results First Received: May 20, 2013
Last Updated: March 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Bipolar Disorder
Generalized Anxiety Disorder
Double-blind
Placebo-controlled
Ziprasidone

Additional relevant MeSH terms:
Anxiety Disorders
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes
Ziprasidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 22, 2014